CN114617572A

CN114617572A - Ultrasound probe fixture, ultrasound imaging system and method of using the same

Info

Publication number: CN114617572A
Application number: CN202111517836.5A
Authority: CN
Inventors: W·R·麦克劳克林; S·索厄德斯; A·K·米森纳
Original assignee: Bard Access Systems Inc
Current assignee: Bard Access Systems Inc
Priority date: 2020-12-14
Filing date: 2021-12-13
Publication date: 2022-06-14
Also published as: CN217138094U; WO2022132651A1; EP4258997A1; US20220183657A1

Abstract

Ultrasound probe fixtures, ultrasound imaging systems, and methods of using the systems are disclosed herein. The fixing device may include: a probe coupling mechanism for coupling the ultrasound probe to the fixture; a patient coupling mechanism for coupling the fixation device to a patient; and a constraining mechanism for maintaining acoustic coupling of the ultrasound probe with the patient during the ultrasound procedure without user intervention.

Description

Ultrasound probe fixture, ultrasound imaging system and method of using the same

Priority

This application claims priority from U.S. provisional application No. 63/125,380, filed on 12/14/2020 and incorporated herein by reference in its entirety.

Technical Field

The present application relates to the field of medical instruments, and more particularly to an ultrasound probe fixture, an ultrasound imaging system, and a method of using the system.

Background

There are currently various existing ultrasound imaging systems that include an ultrasound probe connected to a visual display. Ultrasound imaging systems may be used by clinicians to provide imaging of one or more blood vessels depending on the position of a medical device (e.g., a catheter) within a patient's body. In some cases, a clinician may manually set the position of the ultrasound probe to facilitate imaging of a defined portion of a patient. In other cases, the clinician may manually maintain the set probe position during the medical procedure. In some cases, such as insertion of a catheter, it may be awkward or difficult for a single clinician to manually hold the position of the probe while performing a medical procedure. For example, a clinician may need to use one hand to perform a medical procedure while using the other hand to maintain the position and orientation of the probe. In some cases, it may be advantageous for a clinician to perform a medical procedure using two hands. For example, it may be advantageous for a clinician to accurately insert a needle into a target vein using both hands while viewing an ultrasound image. Similarly, in some cases, the clinician may need to perform tasks remotely from the patient while obtaining ultrasound images. Therefore, there is a need to maintain the position of an ultrasound probe without intervention by a clinician.

Embodiments of an apparatus and method for securing an ultrasound probe relative to a patient to enable ultrasound imaging of the patient without the need for hand-holding are disclosed herein.

Disclosure of Invention

Briefly, an ultrasound probe securement device for securing an ultrasound probe to a patient is disclosed herein. The fixing device includes: a probe coupling mechanism for coupling the ultrasound probe to the fixture; a patient coupling mechanism for coupling the fixation device to a patient; and a constraining mechanism that maintains acoustic coupling of the ultrasound probe with the patient during the ultrasound procedure without user intervention.

In some embodiments, the ultrasound signal from the ultrasound probe passes through the fixation device into the patient. In some embodiments, the fixture includes an acoustic coupling material to facilitate transmission of the ultrasound signal through the fixture.

The fixation device may be configured to constrain the ultrasound probe in an established position and/or orientation relative to the patient. In some embodiments, the fixation device is configured to maintain acoustic coupling of the ultrasound probe with the patient during ultrasound imaging of the blood vessel and/or during insertion of the medical device into the blood vessel.

In some embodiments, the probe coupling mechanism includes a frame including at least one clamping member to attach the fixation device to the ultrasound probe, and the patient coupling mechanism includes an adhesive layer configured to attach the fixation device to the patient. In some embodiments, at least a portion of the adhesive layer comprises an acoustic coupling material.

In some embodiments, the fixation device includes a top friction surface configured to prevent sliding displacement of the ultrasound probe relative to the fixation device and a bottom friction surface configured to prevent sliding displacement of the fixation device relative to the patient.

In some embodiments, the fixture includes a container that includes an acoustic coupling material. The container may also include a high density material to facilitate coupling of the fixation device to the patient via gravity. The container may include an outer compartment containing a high density material. In some embodiments, the outer compartments include a first outer compartment extending away from the ultrasound probe on a first side and a second outer compartment extending away from the ultrasound probe on a second side opposite the first side, and wherein the first outer compartment and the second outer compartment contain the high-density material. In some embodiments, the container includes an interior compartment that houses the acoustic coupling material.

In some embodiments, the fixation device includes one or more fixation straps configured to extend around a portion of the patient.

In some embodiments, the fixation device includes a circumferential wall configured to 1) extend between the ultrasound probe and the patient, 2) couple to the ultrasound probe at a top end of the circumferential wall, and 3) sealably couple to the patient at a bottom end of the circumferential wall to define a closed compartment between the ultrasound probe and the patient. The fixture may maintain acoustic coupling of the ultrasound probe with the patient when a vacuum is present within the enclosed compartment. The circumferential wall may include a bellows (bellows) configured to bias the circumferential wall toward the extended state to at least partially define a vacuum within the enclosed compartment. The closed compartment may also contain an acoustic coupling material. The fixation device may further comprise a lateral wall coupled with an inner surface of the circumferential wall. The lateral wall extends across the enclosed compartment to define a top end of the enclosed compartment. The lateral wall may comprise an acoustic coupling material.

Also disclosed herein is an ultrasound imaging system comprising: an ultrasound probe comprising a user interface and a probe housing; a display; a console operatively coupled to the ultrasound probe and the display, the console configured to process the ultrasound signals and present the ultrasound images on the display; and a fixture configured to maintain acoustic coupling of the ultrasound probe with the patient during use of the ultrasound imaging system.

In some embodiments of the system, the user interface includes a user interface housing separate from the probe housing, and the ultrasound probe is operably coupled to the user interface. In some embodiments, both the user interface and the display are disposed within the probe housing. In some embodiments, the display is attached to the ultrasound probe and the display is pivotably attached to the ultrasound probe.

In some embodiments of the system, the probe housing includes a height dimension extending away from the patient during use and a lateral dimension extending along the patient during use, wherein the lateral dimension is greater than the height dimension.

In some embodiments of the system, the fixture includes an acoustic coupling material, and the fixture may include a container (e.g., a bag) that contains the acoustic coupling material. The container may also contain a high density material.

In some embodiments of the system, the fixture is configured to maintain acoustic coupling of the ultrasound probe with the patient via a suction force.

In some embodiments of the system, the fixture includes a top friction surface configured to prevent sliding displacement of the ultrasound probe relative to the fixture and a bottom friction surface configured to prevent sliding displacement of the fixture relative to the patient.

A method of using an ultrasound imaging system is also disclosed herein. The method includes obtaining an ultrasound imaging system, wherein the ultrasound imaging system includes an ultrasound probe, a user interface, a display, and a console operatively coupled to the ultrasound probe, the user interface, and the display. The console is configured to process the ultrasound signals and present the ultrasound images on the display. The method also includes coupling the ultrasound probe to a fixture and coupling the fixture to the patient, wherein the fixture includes an acoustic coupling material.

In some embodiments, the method further comprises manually positioning the ultrasound probe relative to the patient to establish acoustic coupling of the ultrasound probe with the patient.

In some embodiments of the method, the fixture is configured to constrain the ultrasound probe in the established position without user intervention, and wherein the method further comprises constraining the ultrasound probe in the established position with the fixture.

In some embodiments, the method further comprises obtaining an ultrasound image of the blood vessel while the ultrasound probe is constrained by the fixation device, and the method may further comprise inserting the medical device into the blood vessel while the ultrasound probe is constrained by the fixation device.

In some embodiments of the method, the fixture includes a top friction surface configured to prevent sliding displacement of the ultrasound probe relative to the fixture and a bottom friction surface configured to prevent sliding displacement of the fixture relative to the patient.

In some embodiments of the method, the holding device comprises a container (e.g., a bag) containing the acoustic coupling material. The container may be coupled to the ultrasound probe, and the container may include a first compartment extending away from the ultrasound probe on a first side and a second compartment extending away from the ultrasound probe on a second side opposite the first side. The first compartment and the second compartment contain a high density material.

In some embodiments of the method, the fixture is configured to establish a closed compartment between the ultrasound probe and the patient, and the method may further comprise applying a downward force on the ultrasound probe to expel the contents out of the closed compartment, such that upon release of the downward force, a vacuum is formed within the closed compartment to restrain the ultrasound probe in the established position without user intervention.

These and other features of the concepts provided herein will become more readily apparent to those skilled in the art in view of the drawings and following description, which describe in greater detail certain embodiments of such concepts.

Drawings

A more particular description of the disclosure will be rendered by reference to specific embodiments thereof which are illustrated in the appended drawings. It is appreciated that these drawings depict only typical embodiments of the invention and are therefore not to be considered limiting of its scope. Exemplary embodiments of the invention will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:

fig. 1A provides a view of an ultrasound environment including an ultrasound imaging system having an ultrasound probe secured to a patient, in accordance with some embodiments.

Fig. 1B provides a view of an ultrasound imaging system having an ultrasound probe integral with an operator (user) interface coupled to a display, according to some embodiments.

Fig. 1C provides a view of an ultrasound imaging system having an ultrasound probe including a display and an operator interface enclosed in a single probe housing, in accordance with some embodiments.

Fig. 1D provides a view of an ultrasound imaging system with a display pivotally attached to an ultrasound probe, in accordance with some embodiments.

Figure 1E provides a view of an ultrasound imaging system with a display attached to an ultrasound probe via a post, according to some embodiments.

Fig. 2A provides a side view of an ultrasound probe and fixture, wherein the fixture includes an adhesive layer, according to some embodiments.

Fig. 2B provides a perspective view of the fixation device of fig. 2A according to some embodiments.

Fig. 3A provides a front perspective view of a fixture configured to couple an ultrasound probe to a patient via a suction force, according to some embodiments.

Fig. 3B is a cross-sectional view of the fixture of fig. 3A, wherein the fixture is coupled to an ultrasound probe, according to some embodiments.

Fig. 3C is a side cross-sectional view of another embodiment of a fixation device according to some embodiments, wherein the fixation device is configured to couple an ultrasound probe to a patient via a suction force.

Fig. 4 provides a view of a fixture for use with an ultrasound probe and having a top friction surface and a bottom friction surface, according to some embodiments.

Fig. 5A provides a top perspective view of a fixture according to some embodiments, wherein the fixture includes a container.

Fig. 5B provides a view of the fixture of fig. 5A in use with an ultrasound probe, according to some embodiments.

Fig. 6A provides a top perspective view of a fixture according to some embodiments, wherein the fixture includes a container having a plurality of compartments.

Fig. 6B provides a cross-sectional view of the fixture of fig. 6A in use with an ultrasound probe, according to some embodiments.

Fig. 7 provides a view of a fixture for use with an ultrasound probe and including a strap, according to some embodiments.

Fig. 8 provides a block diagram of a console of an ultrasound imaging system according to some embodiments.

Detailed Description

Before disclosing in greater detail some specific embodiments, it should be understood that the specific embodiments disclosed herein do not limit the scope of the concepts presented herein. It is also to be understood that particular embodiments disclosed herein may have features that can be readily separated from the particular embodiments and optionally combined with or substituted for features of any of the numerous other embodiments disclosed herein.

With respect to the terminology used herein, it is also to be understood that these terminology is for the purpose of describing some particular embodiments, and that these terminology is not intended to limit the scope of the concepts provided herein. Ordinals (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps in a group of features or steps, and do not provide sequential or numerical limitations. For example, "first," "second," and "third" features or steps do not necessarily occur in that order, and a particular embodiment that includes such features or steps is not necessarily limited to three features or steps. For convenience, labels such as "left", "right", "top", "bottom", "front", "back", etc. are used and are not intended to imply, for example, any particular fixed position, orientation, or direction. Rather, such indicia are used to reflect, for example, relative position, orientation, or direction. The singular forms "a", "an" and "the" include plural referents unless the context clearly dictates otherwise. As used herein, including the claims, the words "comprise," have, "and" contain "shall have the same meaning as the word" comprising.

Finally, in the following description, the terms "or" and/or "as used herein should be interpreted as being inclusive or meaning any one or any combination. As an example, "A, B or C" or "A, B and/or C" refers to any one of the following: a; b; c; a and B; a and C; b and C; A. b and C. An exception to this definition will occur only when a combination of elements, components, functions, steps or acts are in some way inherently mutually exclusive.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art.

Embodiments disclosed herein relate to an ultrasound probe fixture for use with an ultrasound imaging system to enable a clinician to perform additional tasks, such as placing a needle into a patient while obtaining ultrasound images. In particular, embodiments disclosed herein enable an ultrasound probe to remain stationary in an established position (i.e., position and/or orientation) relative to a patient without manual contact (intervention) by a clinician. The fixture may also acoustically couple the ultrasound probe to the skin of the patient.

In some embodiments, the fixation device may be integral with the ultrasound probe, and thus, may be configured for multiple uses between different patients. In other embodiments, the fixture may be separate from the ultrasound probe. Also, the separate securement devices may be configured for multiple use or single use (i.e., disposable) between patients. According to some embodiments, an ultrasound imaging system may be configured to take ultrasound images of a medical device insertion site. In some embodiments, the ultrasound imaging system may be configured to provide real-time imaging of the needle relative to the target vessel.

In some embodiments, the ultrasound probe may include an integral or detachable needle guide, such as, for example, the needle guide described in U.S. patent No. 10,863,970 entitled "needle guide including enhanced visibility entry" filed on 23.12.2014, which is hereby incorporated by reference in its entirety. In some embodiments, the fixation device may be coupled to or otherwise engaged with the needle guide. According to exemplary embodiments, an ultrasound imaging system may be used during catheterization to ensure proper placement, where examples of such catheters include, but are not limited to, peripherally inserted central venous catheters (PICCs) or peripheral venous catheters (PIVCs). Such a system may also be used during subsequent stay evaluations.

In some cases, acoustic coupling of the ultrasound probe to the patient's skin is enhanced using an acoustic coupling material, such as a gel substance. The clinician may apply a gel to the head of the ultrasound probe or the skin of the patient to establish an acoustic coupling between the probe head and the skin. In some cases, the presence of a space and/or air pocket between the probe head and the skin will reduce, inhibit or eliminate acoustic coupling. The acoustic coupling material may be any substantially incompressible material, such as water. The acoustic coupling material may be a solid, a liquid, a gel, or a combination thereof.

Referring to fig. 1A, a view of an ultrasound environment including an ultrasound imaging system 100 having an ultrasound probe 110 secured to a limb 180 of a patient is shown, according to some embodiments. The ultrasound imaging system 100 includes an ultrasound probe 110 connected to an ultrasound imaging device 120. In some embodiments, the ultrasound probe 110 may have a needle guide (not shown) attached to the probe 100. The ultrasound imaging system depicted in fig. 1A is capable of ultrasound imaging of blood vessels within a patient's body, and in some embodiments, needle tracking imaging can be combined with blood vessel imaging. The ultrasound imaging system 100 may be used for needle insertion or for insertion site evaluation or for anatomical scanning.

As shown in fig. 1A, the ultrasound imaging system 100 may include a user interface 115 coupled to an ultrasound probe 110 and a display 120. In some embodiments, the ultrasound probe 110, the user interface 115, and the display 120 may be coupled together via a wired connection. In other embodiments, the ultrasound probe 110, the user interface 115, and the display 120 may be wirelessly coupled together. The user interface 115 may include one or more buttons, and the clinician may manipulate the user interface 115 to operate the ultrasound imaging system 100. In use, the user interface 115 may be selectively positioned proximate to or remote from the ultrasound probe 110 and/or the display 120, which may be convenient for a clinician. In some embodiments, the user interface 115 may include a user interface housing 116.

The ultrasound probe 110 includes a probe housing 111. The ultrasound probe 110 includes an ultrasound transducer (not shown), and may include other electrical components (not shown) disposed within the housing 111.

In use, the probe head 112 of the ultrasound probe 110 may be placed in contact with the skin 190 of the patient such that the ultrasound probe 110 may transmit ultrasound signals into the patient. The clinician may manipulate the ultrasound probe 110 to establish or enhance the acoustic coupling of the probe head 112 with the skin 190. In other words, the clinician may manipulate the ultrasound probe 110 to remove any space and/or air pockets between the probe head 112 and the patient's skin 190. In some cases, the clinician may place an acoustic coupling material (sometimes referred to as an acoustically transparent material), such as a gel-like substance, between the head 112 and the skin 190 to facilitate or enhance transmission of the ultrasound signals.

In some embodiments, the probe housing 111 may be shaped to prevent positional changes via contact with items such as clothing, bedding, and the like. In such an embodiment, the probe housing 111 may include a lower profile as shown in FIG. 1A. In some embodiments, the ultrasound probe 110 can include a height dimension extending away from the patient that is less than one or more lateral dimensions extending along the patient.

In some embodiments as shown in fig. 1B, the ultrasound probe 110 may integrally include a user interface 115. In other words, the user interface 115 may be included within the probe housing 111. In some embodiments, the ultrasound probe 110/user interface 115 combination may be coupled to the display 120 via a wired connection. In other embodiments, the ultrasound probe 110/user interface 115 combination may be wirelessly coupled to the display 120.

In some embodiments, the probe housing 111 may be shaped to be grasped and manually manipulated by a clinician. In some embodiments, the probe housing 111 may be shaped to facilitate the ultrasound probe 110 applying a downward force to the patient. The probe housing 111 may be shaped to assist the clinician in rotating or otherwise adjusting the orientation of the ultrasound probe 110. In some embodiments, the ultrasound probe 110 can include a height dimension extending away from the patient that is greater than one or more lateral dimensions extending along the patient.

In some embodiments as shown in fig. 1C, the ultrasound probe 110 may integrally include a user interface 115 and a display 120. In other words, the user interface 115 and the display 120 may both be included within the probe housing 111.

In some embodiments as shown in fig. 1D, the display 120 may be pivotably attached to the ultrasound probe 110. In use, the clinician may pivot the display 120 under an angle to facilitate viewing the display 120 from a convenient direction. In some embodiments, the display may be pivotally positionable between a storage position in which the display 120 is disposed parallel to the ultrasound probe 110, i.e., at an angle of "0" zero degrees relative to the probe, and an upright position in which the display 120 is disposed perpendicular to the ultrasound probe 110, i.e., at an angle of 90 degrees relative to the ultrasound probe 110. In some embodiments, the display 120 may be pivotally positioned at an angle between 90 degrees and 180 degrees relative to the probe.

In some embodiments as shown in fig. 1E, the display 120 may be attached to the ultrasound probe 110 via a post 123. The post 123 may include one or more finger grips 126. The display 120 may be attached to the post 126 in a fixed orientation. In some embodiments, the display 120 may be attached to the post 126 via a ball and socket mechanism (not shown) to allow the clinician to adjust the orientation of the display 120 relative to the ultrasound probe 110.

Fig. 2A and 2B illustrate a fixture 200 configured to attach to an ultrasound probe 110, according to some embodiments. Fig. 2A shows a front view of the fixture 200 detached from the ultrasound probe 110. Fig. 2B is a perspective view of the fixation device 200. The fixation device 200 includes a probe coupling mechanism 210 and a patient coupling mechanism 220. The probe coupling mechanism 210 includes a frame 212 that includes one or more grips 214 configured to grip onto the ultrasound probe 110 at the probe head 112. The ultrasound probe 110 may include one or more recesses, lugs, protrusions, or similar structures to facilitate the clamping attachment of the fixture 200 to the ultrasound probe 110. After use, the fixture 200 may be loosened or otherwise separated from the ultrasound probe 110.

The patient coupling mechanism 220 includes an adhesive layer 222. The adhesive layer is attached to the frame 212. The adhesive layer 222 may comprise an acoustic coupling material. In some embodiments, the adhesive layer 222 may extend radially outward from the frame 212, as shown in fig. 2B. In other embodiments, the adhesive layer 222 may be disposed within the perimeter of the frame 212. The frame 212 includes an opening 215 to facilitate direct contact between the probe head 112 and the adhesive layer 222. In some embodiments, the adhesive layer 222 may be configured to not adhere to the probe head 112. The adhesive layer 222 may be flexible so that a clinician can change the shape of the adhesive layer 222 to conform to the skin surface of a patient. Altering the shape of the adhesive layer 222 can establish or enhance the acoustic coupling of the probe head 112 to the skin 190.

In some embodiments, the adhesive layer 222 may comprise a pressure adhesive comprising a backing paper. In such an embodiment, the adhesion of the adhesive layer 222 may be achieved by removing the backing paper. The adhesive layer 222 may be configured to adhere to the skin 190 of the patient. In some embodiments, the adhesive layer 222 may be made of an adhesive that is one or more of biocompatible, acoustically conductive (or has low acoustic interference), and/or includes a high coefficient of friction. In some embodiments, after use, the adhesive layer 222 may be separated from the frame 212 and replaced with a new adhesive layer 222.

Fig. 3A and 3B illustrate an embodiment of a fixture 300 configured to couple the ultrasound probe 110 to a patient via a suction force. Fig. 3A is a front perspective view of the fixture 300 attached to the ultrasound probe 110. Fig. 3B is a front cross-sectional view of the fixture 300 attached to the ultrasound probe 110. The fixture 300 includes a probe coupling mechanism 310 and a patient coupling mechanism 320. The fixture 300 may be made of an elastomeric material, such as silicone, polyurethane, rubber, or any other suitable flexible material. The probe coupling mechanism 310 may include a circumferential wall 312 and a lateral wall 325 (see fig. 3B) coupled to and extending inwardly from the circumferential wall 312 to form an upper compartment 315 of the probe coupling mechanism 310. The probe coupling mechanism 310 may be configured to telescope to overlie the probe head 112 such that the probe head 112 is at least partially disposed within the upper compartment 315. The top surface 316 of the lateral wall 325 facing the probe head 112 is shaped to facilitate acoustic coupling with the probe head 112. The lateral walls 325 may comprise an acoustic coupling material.

The patient coupling mechanism 320 of the fixation device 300 includes a lower portion of the circumferential wall 312 having a bottom edge 323. The bottom edge 323 is configured to be sealably coupled to the patient's skin 190. As such, when the fixation device 300 is applied to a patient, the circumferential wall 312, the lateral wall 325, and the skin 190 of the patient form a closed lower compartment 328. In use, the clinician may apply a downward force on the ultrasound probe 110 to create a positive pressure within the lower compartment 328. This positive pressure may force air or other contents of the lower compartment 328 to pass between the bottom edge 323 and the skin 190 and out of the lower compartment 328 such that when the downward force is removed, a vacuum is created in the lower compartment 328. The vacuum in the lower compartment 328 creates a suction force between the fixture 300 and the skin 190, thereby securing the ultrasound probe 110 to the patient. In some embodiments, the lower compartment 328 may contain an acoustic coupling material to establish or enhance acoustic coupling between the probe head 112 and the skin 190. In such an embodiment, the acoustic coupling material may be expelled from the lower compartment 328 when the clinician applies a downward force. The bottom surface 326 may be flat, concave, or convex.

Fig. 3C is a front cross-sectional view of a fixture 350 coupled to the ultrasound probe 110, the fixture 350 configured to couple the ultrasound probe 110 to a patient via a suction force. The securing device 350 may be formed from an elastomeric material such as silicone, polyurethane, rubber, or any other suitable stretchable material. The probe coupling mechanism 360 includes a circumferential wall 362 configured to form a telescoping sleeve portion 363. The sleeve portion 363 can telescope over the probe head 112 to couple to the ultrasound probe 110 and form a seal with the probe head 112.

The fixture 350 includes a lower portion of the circumferential wall 362 having a bottom edge 372. The bottom edge 372 is configured to be sealably coupled to the skin 190 of the patient. As such, when the fixture 350 is applied to a patient, the circumferential wall 362, the probe head 112, and the skin 190 of the patient form an enclosed compartment 378. The circumferential wall 362 may be configured to be biased toward the extended state. In some embodiments, the circumferential wall 362 may include a bellows 375 as a biasing member. In use, the acoustic coupling material 358 may be disposed within the compartment 362 prior to coupling with the patient to establish or enhance acoustic coupling between the probe head 112 and the skin 190. During attachment, the clinician may exert a downward force on the ultrasound probe 110 to compress the circumferential wall 362 and pass the acoustic coupling material 358 between the bottom edge 372 and the skin 190 and out of the compartment 378. When the downward force is removed, the circumferential wall 362 may re-extend toward the extended state and thereby create a vacuum within the compartment 378. The vacuum in compartment 328 creates a suction force between fixture 350 and skin 190, thereby securing ultrasound probe 110 to the patient.

Fig. 4 provides a view of a fixture 400 in the form of a flexible pad disposed between the ultrasound probe 110 and the skin 190 of the patient. The fixture 400 includes a top friction surface 411. The top friction surface 411 may prevent sliding of the ultrasound probe 110 relative to the fixture 400. Similarly, the fixture 400 includes a bottom friction surface 421. The bottom friction surface 421 may prevent slippage of the fixation device 400 relative to the skin 190. In some embodiments, the top frictional surface 411 and/or the bottom frictional surface 421 may include one or more adhesive portions to supplement the frictional surfaces 411, 421. The fixture 400 may include or be formed from an acoustic coupling material. In this way, the fixture 400 may acoustically couple the ultrasound probe 110 to the skin 190. In some embodiments, the fixation device 400 may comprise a high density material.

Fig. 5A and 5B show a fixation device 500 in the form of a container (e.g., a bag) disposed between the ultrasound probe 110 and the skin 190 of the patient. Fig. 5A shows a perspective view of the fixture 500 and fig. 5B shows the fixture 500 arranged between the ultrasound probe 110 and the skin 190 of the patient. The fixture 500 includes a vessel 510 defining an outer compartment 520 and an inner compartment 530. In some embodiments, the outer compartment 520 and the inner compartment 530 may be combined to form a single compartment. The container 510 comprises a flexible material so that the container 510 can conform to the contours of the patient. In some embodiments, the material may be stretchable and enable acoustic transmission/coupling. An example of such a material is a urethane polymer bag filled with a high viscosity acoustic gel. The container 510 may be made from a flat sheet of material, or the container 510 may be made from a material that includes one or more pre-formed shapes.

The inner compartment 520 may contain an acoustic coupling material 535. In use, the inner compartment 520 may be disposed between the probe head 112 and the skin 190 such that the acoustic coupling material 535 may facilitate transmission of ultrasound signals through the immobilization device 500 into the patient. In some embodiments, the inner compartment 520 may comprise a preformed shape, such as a central depression in the fixation device 500. As such, the inner compartment 520 may be configured to receive at least a portion of the probe head 112, thereby at least partially constraining the position and/or orientation of the ultrasound probe 110 relative to the fixture 500. In some embodiments, the receptacle 510 may include an outer friction surface 515 to resist sliding displacement between the fixture 500 and the probe head 112 and between the fixture 500 and the skin 190.

The outer compartment 520 may contain a high density material 525. The density of high-density material 525 may be between about 0.5 grams per milliliter and 1.0 grams per milliliter (g/ml), between 1.0 and 1.5g/ml, between 1.5 and 2.0g/ml, or greater than about 2.0 g/ml. The outer compartment 520 may also contain an acoustic coupling material. High density material 525 may include a liquid, gel, particulate, powder, or any combination thereof. In some embodiments, the outer compartment 520 and the inner compartment 530 may combine to form a single compartment that houses the acoustic coupling material and/or the high density material 525.

Fig. 6A and 6B illustrate a fixture 600 in the form of a container that includes an opening 630. Fig. 6A shows a perspective view of a fixture 600 and fig. 6B shows a cross-sectional view of the fixture 600 used with an ultrasound probe 110 that may be applied to a limb 180 of a patient. The fixture 600 includes at least a first compartment 610 and a second compartment 620 that extend laterally away from the opening 630 on opposite sides of the opening 630. The first compartment 610 and the second compartment 620 may be separate flexible portions (e.g., containers) or they may be in a single portion (e.g., container) together. The

compartments

610, 620 may comprise a flexible material such that the

compartments

610, 620 may conform to the contours of the patient. In some embodiments, the material may be stretchable. The fixture 600 may be made from a flat sheet of material, or the fixture 600 may be made from a material that includes one or more pre-formed shapes.

In some embodiments, the opening 630 may be shaped and sized to receive at least a first portion of the ultrasound probe 110 therethrough. In some embodiments, the opening 630 may also be shaped and sized to at least block passage of the second portion of the ultrasound probe 110. In some embodiments, the opening 630 may be shaped and sized to at least prevent a portion of the probe head 112 from passing through the opening 630. In this exemplary embodiment, the fixture 600 is configured to be placed over the ultrasound probe 110 such that the probe head 112 is constrained between the fixture 600 and the skin 190.

As shown in fig. 6B, in use, the

compartments

610, 620 extend downwardly on opposite sides of the limb 180. The fixture 600 may be configured to apply a downward force 640 of the probe head 112 against the patient's skin 190. In some embodiments, the downward force 640 may be defined by the weight of the fixture 600, which may be substantially defined by the combined weight of the contents of the

compartments

610, 620. The force 640 may be large enough to facilitate obtaining an ultrasound image of the patient, but small enough to prevent pain to the patient and/or prevent the patient's tissue from being compressed.

The

compartments

610, 620 may contain a high density material 625. The

compartments

610, 620 may also contain acoustic coupling material. High density material 525 may include a liquid, gel, particulate, powder, or any combination thereof.

Referring to fig. 7, a fixture 700 including one or more straps 710 is shown according to some embodiments. The fixture 700 may include a backing portion 720 that couples the band to the probe head 112. In use, the pad portion 720 may be disposed between the probe head and the skin 190. The backing portion 720 can include an acoustic coupling material to acoustically couple the probe head 112 to the skin 190. In some embodiments, the backing portion 720 includes an opening for the probe head 112 to pass through, such that the probe head 112 can directly contact the skin 190. The strap 710 may be configured to wrap around the patient's limb 180. The strap 710 may include one or more fastening components, such as buckles, latches, hook and loop systems, or any component suitable for attaching the strap 710 to itself or the padded portion 720. The band 710 may be flexible and/or stretchable. The fixture 700 may include 1, 2, 3, or more straps 710. In some embodiments, the band 710 may be configured to attach directly to the skin via an adhesive. In some embodiments, the strap 710 may be attached directly to the ultrasound probe 110, in which embodiment the pad portion 720 may be omitted.

Each of the

fixtures

200, 300, 400, 500, 600, and 700 shown and described above may be combined with any of the embodiments of the ultrasound probe 110 shown in fig. 1A-1E.

Referring to fig. 8, a block diagram of an ultrasound imaging system 100 (any of fig. 1A-1E) including a console 800 is shown, according to some embodiments. The console 800 may be integral to the ultrasound probe 110 or coupled to the ultrasound probe 110. Similarly, the console 800 may be integrated into the display 120 or coupled to the display 120. In some embodiments, the console 800 may be integrated into the display 120 and the ultrasound probe 110. The ultrasound probe 110 includes one or more ultrasound transducers 820 and the display 120 includes a screen 840. The console 800 of the ultrasound imaging system 100 includes a processor 810 for managing system functions by employing a general purpose operating system 812, memory 816, and application programs 814 that may be stored in the memory 816 and executed by the processor 810. Memory 816 may include non-transitory computer storage media. The application 814 may include a user interface 115 to allow a user (i.e., a clinician or doctor) to operate the ultrasound imaging system 100. A beamforming tool 818 including appropriate circuitry is also controlled by the processor 810 to enable the generation, reception and processing of ultrasound signals. For example, the beamforming tool 818 may generate a number of signals that may be reflected and received by one or more ultrasound transducers 820.

One or more ultrasound transducers 820 transmit these signals into the region of the patient and receive reflected ultrasound signals. The beamforming tool 818 may process the reflected ultrasound signals, which are converted to electrical signals by the one or more ultrasound transducers 820, and the beamforming tool may convert the electrical signals to image data. The image data is passed to the display 120 for viewing by a user (i.e., clinician) on the screen 840. The operator interface 115 may include buttons 830 including a power button and control buttons for operating the ultrasound imaging system 100. Note that console 800 may include different, fewer, or more components than those listed herein, including those that enable ultrasound imaging system 100 to operate in a wireless network with other local or remote image processing devices.

Embodiments of the invention may be embodied in other specific forms without departing from the spirit of the disclosure. The described embodiments are to be considered in all respects only as illustrative and not restrictive. The scope of the embodiments is, therefore, indicated by the appended claims rather than by the foregoing description. All changes which come within the meaning and range of equivalency of the claims are to be embraced within their scope.

Claims

1. An ultrasound probe securement device for securing an ultrasound probe to a patient, the securement device comprising:

a probe coupling mechanism for coupling an ultrasound probe to the fixture;

a patient coupling mechanism for coupling the fixation device to a patient; and

a constraining mechanism to maintain acoustic coupling of the ultrasound probe with the patient during an ultrasound procedure without user intervention.

2. A fixation device as claimed in claim 1, wherein, during use, ultrasound signals from the ultrasound probe pass through the fixation device into the patient.

3. A fixation device as claimed in claim 1 or 2, characterized in that the fixation device is configured to constrain the ultrasound probe in a determined position relative to the patient.

4. A fixture according to any one of claims 1-3, wherein the fixture is configured to constrain the ultrasound probe in an established orientation relative to the patient.

5. The fixture according to any one of claims 1 to 4, wherein the fixture is configured to maintain acoustic coupling of the ultrasound probe with the patient during ultrasound imaging of a blood vessel.

6. A fixation device as claimed in any one of claims 1 to 5, wherein the fixation device is configured to maintain acoustic coupling of the ultrasound probe with the patient during insertion of a medical device into a blood vessel.

7. A fixture according to any one of claims 1 to 6, wherein the fixture comprises an acoustic coupling material to facilitate transmission of ultrasonic signals through the fixture.

8. The fixture of any one of claims 1-7, wherein the probe coupling mechanism comprises a frame, and wherein the frame comprises at least one clamping member configured to attach the fixture to the ultrasound probe.

9. The fixation device of claim 8, wherein the patient coupling mechanism comprises an adhesive layer configured to attach the fixation device to the patient.

10. The fastening device of claim 9, wherein at least a portion of the adhesive layer comprises an acoustic coupling material.

11. The fixture of any one of claims 1-7, wherein the probe coupling mechanism comprises a top friction surface configured to prevent sliding displacement of the ultrasound probe relative to the fixture, and wherein the patient coupling mechanism comprises a bottom friction surface configured to prevent sliding displacement of the fixture relative to the patient.

12. A fixation device as claimed in any one of claims 1 to 7, characterized in that the fixation device comprises a receptacle comprising an acoustic coupling material.

13. The fixation device of claim 12, wherein the container comprises a high density material to facilitate coupling of the fixation device to the patient via gravity.

14. The fixture of claim 13, wherein the container comprises an outer compartment comprising the high density material.

15. A fixation device as claimed in any one of claims 12 to 14, wherein the container comprises an inner compartment comprising the acoustic coupling material.

16. The fixture of any one of claims 12 to 14, wherein the receptacle comprises an opening configured for positioning a portion of the ultrasound probe therethrough.

17. The fixation device of claim 16, wherein the outer compartment comprises a first outer compartment extending away from the opening on a first side and a second outer compartment extending away from the opening on a second side opposite the first side, and wherein the first and second outer compartments contain the high-density material.

18. The fixation device of any one of claims 1 to 7, wherein the patient coupling mechanism comprises one or more fixation straps configured to extend around a portion of the patient.

19. A fixation device as claimed in any one of claims 1 to 7, comprising a circumferential wall configured to:

extending between the ultrasound probe and the patient;

a circumferential wall coupled to the ultrasonic probe at a top end of the circumferential wall; and is

Sealably coupled to the patient at a bottom end of the circumferential wall to define a closed compartment between the ultrasound probe and the patient,

wherein the fixture is configured to maintain acoustic coupling of the ultrasound probe with the patient when a vacuum is present within the enclosed compartment.

20. The fixture of claim 19, wherein the circumferential wall comprises a bellows configured to bias the circumferential wall toward the extended state to at least partially define a vacuum within the enclosed compartment.

21. A fixation device as claimed in any one of claims 19 to 20, wherein the closed compartment contains the acoustic coupling material.

22. The securement device of any one of claims 19 to 21, further comprising a lateral wall coupled to an inner surface of the circumferential wall, the lateral wall extending across the enclosed compartment to define a top end of the enclosed compartment, and wherein at least a portion of the lateral wall comprises the acoustic coupling material.

23. An ultrasound imaging system, comprising:

an ultrasound probe comprising a user interface and a probe housing;

a display;

a console operatively coupled to the ultrasound probe and the display, the console configured to process ultrasound signals and present ultrasound images on the display; and

a fixture configured to maintain acoustic coupling of the ultrasound probe with a patient during use of the ultrasound imaging system.

24. The system of claim 23, wherein the user interface comprises a user interface housing separate from the probe housing, and wherein the ultrasound probe is operably coupled to the user interface.

25. The system of claim 23, wherein the user interface and the display are disposed within the probe housing.

26. The system of any one of claims 23 to 25, wherein the probe housing comprises a height dimension extending away from a skin surface of the patient during use and a lateral dimension extending along the skin surface during use, and wherein the lateral dimension is greater than the height dimension.

27. The system of claim 23, wherein the display is attached to the ultrasound probe.

28. The system of claim 23, wherein the display is pivotably attached to the ultrasound probe.

29. The system of any one of claims 23 to 28, wherein the fixture comprises an acoustic coupling material.

30. The system of any one of claims 23 to 29, wherein the fixture comprises a container comprising the acoustic coupling material.

31. The system of claim 30, wherein the container comprises a high density material.

32. The system of any one of claims 23 to 29, wherein the fixture is configured to maintain acoustic coupling of the ultrasound probe with the patient via a suction force.

33. The system of any one of claims 23 to 29, wherein the fixture comprises a top friction surface configured to prevent sliding displacement of the ultrasound probe relative to the fixture and a bottom friction surface configured to prevent sliding displacement of the fixture relative to the patient.

34. A method of using an ultrasound imaging system, comprising:

obtaining an ultrasound imaging system, the ultrasound imaging system comprising:

an ultrasonic probe;

a user interface;

a display; and

a console operatively coupled to the ultrasound probe, the user interface, and the display, the console configured to process ultrasound signals and present ultrasound images on the display;

coupling the ultrasound probe to a fixture; and

coupling the fixation device to a patient,

wherein the fixture comprises an acoustic coupling material.

35. The method of claim 34, further comprising manually positioning the ultrasound probe relative to the patient to establish the acoustic coupling of the ultrasound probe with the patient.

36. The method of claim 35, wherein the fixture is configured to constrain the ultrasound probe in an established position without user intervention, and wherein the method further comprises constraining the ultrasound probe in the established position with the fixture.

37. The method of any one of claims 34 to 36, further comprising obtaining an ultrasound image of a blood vessel while the ultrasound probe is constrained by the fixation device.

38. The method of claim 37, further comprising inserting a medical device into the blood vessel while the ultrasound probe is constrained by the fixation device.

39. The method of any one of claims 34 to 38, wherein the fixture comprises a top friction surface configured to prevent sliding displacement of the ultrasound probe relative to the fixture and a bottom friction surface configured to prevent sliding displacement of the fixture relative to the patient.

40. The method of any one of claims 34 to 38, wherein the fixture comprises a container comprising the acoustic coupling material.

41. The method of any one of claims 34 to 38, wherein the fixture comprises a container coupled to the ultrasound probe, the container comprising a first compartment extending away from the ultrasound probe on a first side and a second compartment extending away from the ultrasound probe on a second side opposite the first side, the first and second compartments containing a high density material.

42. The method of any one of claims 32 to 36, wherein the fixture is configured to establish a closed compartment between the ultrasound probe and the patient, and wherein the method further comprises exerting a downward force on the ultrasound probe to expel contents out of the closed compartment, such that upon release of the downward force, a vacuum is formed within the closed compartment to restrain the ultrasound probe in the determined position without user intervention.